We specialize in statistical support consulting to bring clarity and confidence to your data. From study design and test method validation to stability programs and production transfer, we apply proven statistical analysis methods to ensure your results are reliable, actionable, and ready to meet regulatory standards. Our experience in medical statistical analysis provides life science companies with the evidence they need to make stronger decisions.
Because no two projects are the same, our statistical consulting services are always tailored to your needs. From test method validation and stability studies to production transfer and ad-hoc statistical analyses, we adapt our methods to combine scientific knowledge with practical execution. With deep experience in life science consulting, we help you achieve reliable results and stronger decisions—right from the start.
Our statistical consulting services are built on Emendo’s mantra: Observe, Think, Improve in everything we do.
Observe: We start by listening and looking closely to your existing data and methods. Giving the context, we review historical information, identify key variable and phrase your challenge
Think: We apply statistical expertise to structure the problem, test hypotheses, and reveal patterns. Using proven methods and modeling, we turn raw numbers into clear insights that support confident decision-making.
Improve: We deliver actionable recommendations and tools that you can use in the future – whether that’s optimized study designs, better control strategies, or custom statistical analysis templates.
Reliable data starts with validated test methods. We use design of experiments (DOE) to optimize method parameters, variance component analysis to quantify variability, and gauge R&R studies to confirm repeatability and reproducibility. Our evaluations cover precision, accuracy, linearity, robustness, and measurement uncertainty, ensuring your methods are reproducible, regulatory-compliant, and provide trustworthy data for confident decision-making.
Stability programs rely on robust statistical analysis methods to establish product shelf life and ensure consistent quality over time. We apply regression analysis, trend evaluation, and variability assessments to detect shifts, quantify uncertainty, and build reliable shelf-life projections. Our statistical consulting for life sciences ensures full compliance with ICH stability guidelines while giving you clear, defensible evidence of product performance throughout its lifecycle.
Scaling up from laboratory development to full-scale manufacturing demands rigorous statistical consulting. We design experiments to identify critical process factors, evaluate process capability, and define robust control strategies. By applying statistical process control (SPC) methods, control charts, and capability analyses, we ensure a smooth technology transfer with consistent, compliant, and high-quality production outcomes.
When unique challenges arise, a tailored statistical support consulting approach delivers the clarity you need. We design and analyze comparability studies to demonstrate product or method equivalence, apply survival and reliability analysis to predict performance over time, and support formulation development with data-driven optimization. Our flexible expertise provides fast, actionable insights grounded in robust statistical analysis methods—helping you solve complex problems with confidence.
CASE SPOTLIGHT
Introducing new product formulations in the medical device industry demands more than just innovation — it requires clear evidence that performance is consistent, reliable, and compliant from the very start. One leading manufacturer partnered with Emendo R&D to strengthen this process with advanced statistical consulting medical devices.
The challenge lay in demonstrating product equivalence while addressing batch-to-batch variability and test method uncertainty. Without the right statistical analysis framework, the risk of inconclusive or unreliable conclusions was high.
By applying structured study design, leveraging gauge R&R analysis, and building a centralized approach to data handling, we created a foundation for confident decision-making in formulation development.
Explore how we helped a MedTech client navigate the EU MDR transition by leading a science-driven material reformulation. The result: a fully compliant device that preserved critical product claims, improved performance, and reduced cost of goods – turning regulatory risk into competitive advantage.
Discover how we supported a client with a strategic competitive threat response when a competitor’s product launch posed a significant threat to their market position.
Discover how we achived cost savings while ensuring compliance with regulatory standards when we supported a client in the development of a user-friendly injection device.
HAVE A QUESTION
Every project comes with unique challenges. Tanguy Floch, Senior Scientific Consultant, helps life science companies turn complex data into clear, reliable insights. Reach out to Tanguy to explore how we can support your needs.
Tanguy Floch
Senior Scientific Consultant
